Orismilast achieves positive results in psoriasis, fast track for hidradenitis suppurativa

Union Therapeutics announced positive results for oral orismilast in a phase 2b study in adult patients with moderate to severe psoriasis, and the FDA also granted the drug fast track designation for hidradenitis suppurativa treatment.

“Patients continue to have significant unmet medical need for indications such as psoriasis, atopic dermatitis and hidradenitis suppurativa, where an efficacious and safe oral treatment is an important new treatment option,” Kim Domela Kjøller, MD, CEO of Union Therapeutics, told Healio.

“The topline results from the phase 2b study with oral orismilast is important as it supports the high potency and hereby the potential as a best- or first-in-class oral PDE4 inhibitor for many immunological diseases,” Kjøller continued.

Kim Kjøller

According to a Union Therapeutics press release, the randomized, double-blind IASOS study evaluated the safety and efficacy of the orismilast modified release tablet in 202 adult patients with moderate to severe plaque psoriasis. Participants received one of three active doses or placebo twice daily for 16 weeks.

Results showed that orismilast data reached statistical significance after 4 weeks of treatment compared with placebo, according to the press release. By week 16, active arms of orismilast achieved the primary endpoint percentage change from baseline in PASI.

Shortly following the release of these topline results, Union Therapeutics issued a press release to announce that the FDA granted fast track designation to orismilast for the treatment of moderate to severe hidradenitis suppurativa.

The FDA grants fast track designations to drug candidates that treat serious conditions and address significant unmet medical needs. These designations allow for more frequent FDA interaction concerning the drug’s development and eligibility for rolling review and priority review.

According to the release, Union Therapeutics plans to discuss the most appropriate endpoints, target disease severity and next steps in the development of the drug with the FDA.

"We are very pleased to receive this fast track designation for oral orismilast in hidradenitis suppurativa and look forward to working closely with the FDA in the design of the clinical development program for oral orismilast,” Kjøller said in the release.

Reference:

• UNION therapeutics receives FDA fast track designation for oral orismilast for the treatment of moderate to severe hidradenitis suppurativa. https://uniontherapeutics.com/union-therapeutics-receives-fda-fast-track-designation-for-oral-orismilast-for-the-treatment-of-moderate-to-severe-hidradenitis-suppurativa/. Posted Jan. 10, 2023. Accessed Jan. 11, 2023.